Fixation device for fixating a catheter relative to a skin surface part of a person

ABSTRACT

A fixation device ( 10 ) for fixating a catheter ( 32 ) relative to a skin surface part of a person. The fixation device comprises a pad element ( 24 ) to be arranged adjacent to the perforation site and defining a convex marginal surface having a radius of curvature of at least one order of magnitude larger than the outer diameter of the catheter. The marginal surface provides a support surface in relation to the catheter positioned in facial contact therewith for arranging the catheter in a loop and turning the catheter from an orientation substantially perpendicularly relative to the skin surface part to an orientation substantially parallel with the skin surface part and for preventing the catheter from sliding along the marginal surface. The fixation device further comprises a cover foil ( 12 ), an adhesive material applied to the first surface of the cover foil, and a connecting foil ( 14 ), for fixating the catheter.

[0001] The present invention relates to a device for fixating anepidural catheter or a similar drainage catheter to a skin surface partof a patient or person.

[0002] The present invention generally relates to the technique ofapplying and fixating a catheter, such as an epidural catheter, relativeto a skin surface part of a patient or person, and more precisely adevice for fixating such a catheter relative to a skin surface part of apatient or person.

[0003] It is a well-known technique to enter a catheter through the skinof a patient or person, e.g. after a surgical operation.

[0004] In certain applications, tiny catheters are to be used which haveto be applied to e.g. the back of the person or patient. The size of thecatheter itself makes the catheter extremely susceptible to blockings incase the catheter is not properly mounted and in case the patient orperson lies on the catheter. The small size of the catheter, e.g. of anepidural catheter also renders it highly likely that the catheter iswithdrawn from its intentional position as the patient or person shiftshis or her position sitting or lying in the bed or is moved to and froma bed, a chair or moves around as the catheter is very easily caught bythe patient or person or caught by a person helping the patient orperson.

[0005] Furthermore, the technique of applying and fixating a catheter,in particular an epidural catheter, is a complex and time-consumingoperation which requires skill and which further often turns out to beinadequate and inappropriate as the epidural catheter is easily pulledout and removed from its intentional position.

[0006] Various devices for fixating a catheter have recently beendeveloped as disclosed in eg. GB patent No. 2,115,290, U.S. Pat. Nos.4,419,094, 4,645,492, 5,282,791, 5,370,627, and 5,372,589, WO 91/07204,WO 91/17738, WO 95/33508, WO 93/25264 and WO 93/17738. Reference is madeto the above patents and patent applications, and the above US patentsare hereby incorporated in the present specification by reference.

[0007] The above-mentioned U.S. Pat. No. 5,372,589 discloses atransparent self-adhesive film dressing with a special aeratingfenestra, which substantially covers and secures an intravenous catheterto the skin of the patient, for visual inspection, without encouraginggrowth of bacteria. Although the above-mentioned film dressing isadvantageous from the point of view of its extremely simpleconstruction, it can only be used in connection with catheters forpercutaneous intubations, which catheters are introduced practicallytangentially to the patient's skin, and not in connection with catheterswhich are introduced perpendicularly to the patient's skin, such asepidural catheters. Application of the self-adhesive film dressingaccording to U.S. Pat. No. 5,372,589 in connection with an epiduralcatheter would cause the epidural catheter to bend brusquely at the exitfrom the puncture point, provoking thus a constriction of the catheterflow channel and impeding an uninterrupted epidural collection and wouldnot prevent the epidural catheter from being pulled out from theposition.

[0008] The above mentioned published international patent application,publication No. WO 93/25264 discloses a device for fixating a drainagetube, and a drainage tube assembly introduced perpendicularly to thepatient's skin, which device comprises a support component including aflange part and a tubular part which are integrally connected through aconical part. The tubular part has a through-going passage for receivingthe drainage tube, and the flange part has a surface part to be arrangedin surface contact with the skin surface part of the patient. The devicealso comprises a locking component for locking the drainage tuberelative to the tubular part of the support component. The particularassembly of the flange part, the conical part and the tubular parteliminates the risk that the drainage tube may bend at the entrance ofthe patient's skin and the risk of creation of kinks in the drainagetube. However, the device according to publication No. WO 93/25264 hasappreciable dimensions in all three coordinates, making it uncomfortablefor the patient if he/she will make a move and squeeze the tube assemblybetween his/her skin and the bed, at the same time provoking also theinterruption of flow in the tube or even the breaking thereof.

[0009] Consequently, none of the existing types of fixation devices havebeen found to meet the requirement of being able to ensure a reliablefixation of a catheter, in particular an epidural catheter, insertedsubstantially perpendicularly relative to the patient's skin.

[0010] An object of the present invention is to provide a device forfixating an epidural catheter or similar catheter, which deviceeliminates the risk that the catheter may bend abruptly at theperforation site in the patient's skin or create kinks, and furtherprevent the catheter from being pulled out in case the catheter isunintentionally squeezed, pressed or in any other way removed from aresting position.

[0011] A particular advantage of the device according to the presentinvention resides in that a single unitary structure is provided whichrenders it possible, in a single and easily performable operation, toaccomplish a secure fixation of the epidural catheter and also make thecatheter and the catheter flow less sensitive to the patient's moves orto external pull, squeeze, press or jerk factors.

[0012] A particular feature of the device according to the presentinvention is the provision of a pad which by its curved shape ensuresthat the epidural catheter by bending over said pad and following theouter contour thereof will form a loop with the same large radius ofcurvature as the above-mentioned pad, and by its thickness and softnessensures that the epidural catheter will not bend abruptly when exitingthe puncture point in the patient's skin.

[0013] A further particular feature of the device according to thepresent invention lies in that the device according to the presentinvention constitutes a disposable unitary structure which has beenpresterilized and is applied in a simple manner as a plaster structureto the patient's skin.

[0014] The above object, the above advantage and the above featurestogether with numerous other objects, advantages and features which willbe evident from the description below are obtained by means of a devicefor fixating an epidural catheter to the skin surface part of a patient,comprising in accordance with the present invention:

[0015] a pad element to be arranged adjacent to the perforation site anddefining a convex marginal surface having a radius of curvature of atleast one order of magnitude larger than the outer diameter of thecatheter, the marginal surface providing a support surface in relationto the catheter positioned in facial contact therewith for arranging thecatheter in a loop and turning the catheter from an orientationsubstantially perpendicularly relative to the skin surface part to anorientation substantially parallelly with the skin surface part and forpreventing the catheter from sliding along the marginal surface,

[0016] a cover foil of a foil material having opposite first and secondsurfaces and defining a first end,

[0017] an adhesive material applied to the first surface of the coverfoil, and

[0018] a connecting foil being connected to the cover foil at the firstend thereof and constituting an extension thereof, the pad element beingconnected to and supported by the connecting foil, the connecting foildefining a transition area between the supporting element and the coverfoil, a folding line being defined within the transition area, the coverfoil being foldable onto the pad element along the folding line forarranging the first surface of the cover foil facing towards the padelement for adhering to the skin surface part, for fixating the catheterrelative to the pad element and for covering the perforation site.

[0019] The pad element of the fixation device according to the presentinvention constitutes an element which serves the dual purpose ofturning the catheter from an orientation substantially perpendicularlyrelative to the skin surface part to an orientation substantiallyparallelly with the skin surface part and supporting the catheter in aloop preventing the catheter from sliding along the marginal surfacedefined by the pad element and consequently preventing the catheter frombeing pulled out or otherwise removed from its intentional positionextending through the skin of the person through the perforation site.

[0020] The fixation device according to the present invention basicallycomprises three main components viz. the pad element characteristic ofthe present invention and serving the above described dual purpose, thecover foil and the connecting foil. The cover foil and the connectingfoil may according to alternative embodiments of the fixation deviceaccording to the present invention be constituted by separate componentsas the connecting foil may be constituted by a separate foil componentor alternatively, the cover foil and the connecting foil may beconstituted by a unitary structure as the connecting foil is integralwith the cover foil and may be constituted by a single foil or sheetelement.

[0021] The terms foil and sheet are in the present context to beconsidered synonymous and are to be considered generic expressions orterms defining a geometric element which has opposite surfaces of fairlylarge dimensions as compared to the overall thickness of the element inquestion. The terms foil and sheet are by no means to be construedlimited to specific materials and interpretations in relation to e.g.plastic materials, however are to be understood covering plastic foilsor sheets and equivalent elements serving the same purpose as plasticfoils or sheets.

[0022] The adhesion of the cover sheet to the skin surface part of theperson in question may be established through configurating the padelement and the cover foil so as to allow the cover foil to cover thepad element and at the same time adhere to the skin surface part.According to the presently preferred embodiment of the fixation deviceaccording to the present invention, the pad element defines a pad areaand the first surface of the cover foil defines an area substantiallyexceeding the pad area. Consequently, in accordance with the abovedescribed preferred embodiment of the fixation device according to thepresent invention, the cover sheet readily adheres to the skin surfacepart of the person in question as the cover sheet is applied coveringthe pad element. It is to be understood that the cover sheet preferablyincludes a complete adhesive covering at its first surface allowing thecover sheet to adhere in facial contact to the pad element and alsoadhere to the skin surface part of the person in question.

[0023] The connecting foil may in accordance with a first embodiment ofthe device according to the present invention be provided with anadhesive covering at a surface thereof coextensive with the surface ofthe cover foil serving the purpose of adhering to the adhesive of thecover foil as the cover foil is folded onto the connecting foil.Additionally or alternatively, the connecting foil is preferablyprovided with an adhesive covering at a surface thereof opposite to thefirst surface of the cover foil and consequently serving the purpose ofcausing the connecting foil to adhere to the skin surface part of thepatient or person prior to the folding of the cover onto the pad elementand the connecting foil and at least temporarily fixating the deviceaccording to the present invention in its intentional position at theperforation site.

[0024] The adhesive covering of the connecting foil at the surfacethereof coextensive with the surface of the cover foil also serves thepurpose of at least temporarily fixating the catheter relative to theconnecting foil as the catheter is arranged in the above described loopand in contact with the adhesive covering of the connecting foil.

[0025] For further improving the fixation of the catheter relative tothe skin surface part of the patient or person, the connecting foilaccording to the above described preferred embodiment of the deviceaccording to the present invention preferably has an extension servingthe purpose of covering and adhering to the catheter.

[0026] Dependent on the configuration of the pad element characteristicof the present invention and also the provision of an adhesive coveringat a surface of the connecting foil coextensive with the surface of thecover foil, the pad element may be provided with an adhesive covering atthe convex marginal surface for causing the catheter in the abovedescribed loop to adhere to the pad element. Additionally oralternatively, the pad element may be provided with an adhesive surfacecovering for adhering to the cover foil as the cover foil is folded ontothe pad element.

[0027] The device according to the present invention preferablycomprises an extension of the connecting foil for covering and adheringto the catheter for improving the fixation of the catheter relative tothe skin surface part. Furthermore or alternatively, the connecting foilmay be provided with a fixation support adjacent the pad element forattaching the catheter to the skin surface part of the patient orperson.

[0028] For improving the main purpose of preventing that the catheter isbent abruptly or blocked, the pad element may be provided with one ormore notches for receiving and fixating the catheter relative to the padelement and consequently supporting and properly securing the catheterrelative to the pad element.

[0029] In order to allow visual inspection of the perforation site andalso allow visual inspection of the arrangement of the catheter relativeto the device according to the present invention and consequentlyrelative to the perforation site, the cover foil may advantageously beprovided with a transparent area allowing visual inspection of theperforation site.

[0030] In order to render it possible to handle the fixation devicebefore applying it to the catheter and to the skin surface part of theperson, to which skin surface part the catheter is to be fixated, thedevice according to the present invention preferably further comprisesrelease foils covering all the adhesive areas. The release foils may beconstituted by a siliconized paper, siliconized or non-siliconizedpolyester, polypropylene, polyethylene or a similar plastic material.

[0031] The cover foil of the fixating device according to the presentinvention may be configurated in an arbitrary shape provided the coverfoil fulfils the above requirement of fixating the catheter and thecatheter-supporting connecting foil relative to the skin surface part.Thus, according to alternative geometrical embodiments of the fixationdevice according to the present invention, the cover foil may be of arectangular configuration, a quadratic configuration, a circularconfiguration, an elliptic configuration or a combination of the aboveconfigurations.

[0032] For preventing the ingress of bacteria into the perforation site,the foil covering the perforation site is preferably made from amaterial providing a bacteria barrier. Provided the cover foil asdiscussed above is provided with a transparent area, the transparentarea is advantageously and preferably covered by a gas and liquidimpermeable and bacteria barrier defining transparent foil.Alternatively, provided the cover foil is provided without a transparentarea, the cover foil or at least a part of the cover foil covering theperforation site is preferably constituted by a material providing abacteria barrier.

[0033] The sheet material of the cover foil of the fixation deviceaccording to the present invention may be made from any appropriatematerial which may be used as a cover foil material. Provided theadhesive layers are substantially water-impermeable, the sheet materialmay be made from water-impermeable or water-permeable material. In orderto hinder any penetration of water through the cover foil from theenvironment into the area covered by the bandage, the sheet material is,however, preferably a substantially water-impermeable material such asspun bond, spun lace, woven or non-woven foil materials of polyester,nylon, polypropylene, polyethylene, polyurethane, polyvinylchloride,clear tape or other transparent or non-transparent material, orcombinations thereof.

[0034] The pads may be made of any appropriate soft material such as afibrous synthetic or natural material, e.g. cotton, viscose, rayon orthe like, synthetic or natural rubber or foamed plastic foils such as apolyester foam, a polyurethane foam, EVA foam (Ethylene Vinyl Acetatefoam).

[0035] The individual components of the fixation device according to thepresent invention including the cover foil, the adhesive covering, theconnecting foil and also any additional adhesives and/or release foilsetc. may readily be chosen by a person having ordinary skill in the artfrom materials which are well-known in the art for medical applicationincluding medical grade supporting element materials, cover foils,release foils, adhesives etc.

[0036] The adhesive layer may be constituted by a medical grade acrylicadhesive, a medical, natural or synthetic rubber resin adhesive or othermedical grade adhesive.

[0037] The invention will now be further described with reference to thedrawings, in which:

[0038]FIG. 1a is a schematic and perspective view of a first embodimentof an epidural catheter fixation device according to the presentinvention,

[0039]FIG. 1b is a schematic and perspective view of the embodiment ofthe epidural catheter fixation device of FIG. 1a, illustrating a firststep of applying the epidural catheter fixation device for fixating anepidural catheter relative to a skin surface part of a person orpatient,

[0040]FIG. 1c is a schematic and perspective view illustrating theepidural catheter of FIG. 1b finally fixated by means of the epiduralcatheter fixation device,

[0041]FIG. 2 is a schematic and perspective view similar to the view ofFIG. 1a of a second embodiment of the epidural catheter fixation deviceaccording to the present invention,

[0042]FIG. 3 is a schematic and perspective view similar to the view ofFIG. 1a of a third embodiment of the epidural catheter fixation deviceaccording to the present invention,

[0043]FIG. 4a is a schematic and perspective view similar to the view ofFIG. 1a of a fourth embodiment of the epidural catheter fixation deviceaccording to the present invention,

[0044]FIG. 4b is a schematic and perspective view similar to the view ofFIG. 1b of the fourth embodiment of the epidural catheter fixationdevice,

[0045]FIG. 5a is a schematic and perspective view similar to the view ofFIG. 1a of a fifth embodiment of the epidural catheter fixation deviceaccording to the present invention,

[0046]FIG. 5b is a schematic and perspective view similar to the view ofFIG. 1c of the fifth embodiment of the epidural catheter fixationdevice, and

[0047]FIG. 6 is a schematic and perspective view of a preferred methodof producing the first embodiment of an epidural catheter fixationdevice according to the present invention shown in FIGS. 1a, 1 b, 1 cand illustrating the multilayer structure of the epidural catheterfixation device.

[0048] In the following examples, parts and elements of differentembodiments of an epidural catheter fixation device having the samefunction are designated the same reference numeral but primed a numberof times, the priming number being one unit less than the number of theembodiment. For example, an element 20 in the first embodiment will bedesignated the reference numeral 20′ in the second embodiment, 20″ inthe third, etc.

[0049] In the following examples and in the claims terms like “lowerside” and “upper side” used in connection with the sides of therespective foils will be construed as meaning “skin-facing side” and“opposite the skin-facing side”, respectively.

[0050] In FIG. 1a a first embodiment of an epidural catheter fixationdevice is designated the reference numeral 10 in its entirety. Theepidural catheter fixation device comprises an oblong, substantiallyrectangular cover foil 12 having a first adhesive side and a secondnon-adhesive side. Centrally the cover foil 12 is provided with aninspection window 30 which is made by removing the respective portion ofthe cover foil providing an aperture within the cover foil 12 which iscovered by a transparent plastic foil. A double adhesive connecting foil14 is further provided defining a broad base having the same width asthe cover foil 12 and is adhesively attached with the broad base to thenon-adhesive side of the cover foil 12 in extension thereto, the broadbase narrowing and then evading and forming a U-shaped foil portion withoutwardly pointing uneven branches.

[0051] On the one side of the double adhesive connecting foil 14,corresponding to the non-adhesive side of the cover foil 12, a first,U-shaped pad 20 with uneven branches is attached, the pad having thesame shape as the evased, U-shaped foil portion of the double adhesiveconnecting foil 14. A substantially U-shaped pad or second pad 24 withsubstantially even branches is adhered to the opposite side of thedouble adhesive connecting foil 14, corresponding to the adhesive sideof the cover foil 12. The substantially U-shaped pad 24 defines an outerconvex marginal surface constituting a support and contact surfaceagainst which a catheter to be fixated by means of the device 10 ispositioned as will be described in greater details below. A third pad 22is adhered to the double adhesive connecting foil 14 at the extremity ofthe longer branch of the double adhesive connecting foil 14 on the sameside thereof as the pad 24. A first release foil 16 covers the adhesiveside of the cover foil 12 and a first adhesive side of the doubleadhesive connecting foil 14. A second release foil 26 covers theopposite side of the double adhesive connecting foil 14 and also coversan adhesive applied to the lower side of the pad 20, and a third releasefoil 28 covers the portion of the second adhesive side of the doubleadhesive connecting foil 14 corresponding to the length of the pad 22. Acontinuous line 18 defines the margin of the cover foil 12, a dashedline 17 defines the margin of the broad base of the double adhesiveconnecting foil 14, and a dashed line 19 defines the margin of the pad20.

[0052]FIG. 1b shows the first embodiment 10 of an epidural catheterfixation device of FIG. 1a in a first step of applying the fixationdevice onto a skin surface part of a person for fixating an epiduralcatheter 32 relative to the skin surface part. Initially, the secondrelease foil 26 shown in FIG. 1a is removed exposing the lower side ofthe double adhesive connecting foil 14 and also the adhesive applied tothe lower side of the pad 20. The fixation device 10 is then positionedadjacent to the perforation site as the U-shaped pad 24 is positionedjuxtaposed the perforation site allowing the epidural catheter 32 to bebent backwardly and supported in recesses 23 also shown in FIG. 1aprovided in the U-shaped pad 24. The epidural catheter 32 perforates theskin perpendicularly to the patient's skin surface part through aperforation site 34 and is bent backwardly relative to the pad 24 andwrapped around the rounded portion of the pad 24 and positioned incontact with the outer convex marginal surface of the pad 24. Theepidural catheter 32 is then positioned below the third pad 22 and belowthe longer extrimetry of the U-shaped pad 20 which is connected to thethird pad 22 through the corresponding longer branch of the doubleadhesive connecting foil 14. The epidural catheter 32 is then fixatedrelative to the skin surface part of the person as the adhesive appliedto the lower side of the pad 20 is caused to adhere to the skin surfaceand also to the epidural catheter 32. The wrapping of the catheter 32around the U-shaped pad 24 firstly ensures that the catheter 32 does notbend brusquely, in an acute angle, which might lead to catheterconstriction and preventing the flow of fluid through the catheter. Thewrapping of the catheter around the pad 24, secondly forms a loop in aplane substantially perpendicular to the plane of the catheterperforating the skin surface at the perforation site and pull relief incase the catheter 32 is pulled, squeezed, pressed, jerked or in anyother way removed from its resting position on the connecting sheet 14,thereby diminishing the discomfort caused to the patient and the riskthat the catheter may be extracted unwillingly from its insertion site.

[0053] Thereupon, the first release foil 16 shown in FIG. 1a is removedas is illustrated in FIG. 1b and the cover foil 12 is bent or foldedonto the connecting foil 14 and also onto the pad 24 supporting theepidural catheter 32 in the above described non-bending and pullrelieving manner as the cover foil 12 is bent along the dashed line 17constituting the margin of the broad base of the support foil 14. As thecover foil 12 is folded onto the pad 24, the perforation site is alsosealed as is illustrated in FIG. 1c disclosing the final positioning ofthe fixation device 10 relative to the skin surface part of the person.As the cover foil 12 is folded onto the pad 24 and also onto the skinsurface part of the person, the adhesive of the lower side of the coverfoil 12 adheres to the skin surface part and also adheres to theepidural catheter 32. In the above described first embodiment, theinspection window 30 allows visual inspection of the perforation siteand also inspection of the position of the epidural catheter supportedby the device. It is to be realized that the epidural catheter is in itsbent wrapped around the pad 24 adhered to the upper adhesive of thedouble adhesive connecting foil 14. Provided the inspection window 30 isnot provided, the epidural catheter is sandwiched between the cover foil12 and adhere to the adhesive of the lower side thereof and the upperadhesive side of the double adhesive connecting foil 14. The sandwichingof the epidural catheter in the bent and wrapped around positionrelative to the pad 24 further improves the fixation of the epiduralcatheter relative to the skin surface part of the person.

[0054]FIG. 2 shows a second embodiment of an epidural catheter fixationdevice 10′ according to the present invention, which embodiment isdesignated the reference numeral 10′ in its entirety and is very similarin construction to the first embodiment 10 presented in FIG. 1a, butdiffering in the position and shape of the U-shaped extension of theconnecting foil 14′. The succession of layers in this second embodimentof the catheter fixation device 10′ is the same as in the firstembodiment, i.e. the first release foil 16′, the U-shaped pad 24′ withsubstantially even branches, one of the branches being provided with twoopposite grooves 23′, the pad 22′ coplanar with the pad 24′, the doubleadhesive connecting foil 14′, the U-shaped pad 20′, the second releasefoil 26′, and the third, intermediate release foil 26′ between thesecond release foil 26 and the end of the longer branch of the U-shapedpad 20′. However, the second embodiment 10′ differs from the firstembodiment 10 in that the U-shaped pad 20′ is shifted 90° relative tothe overall orientation of the double adhesive connecting foil 14′ andthe cover foil 12′ as compared to the orientation of the pad 24 inrelation to the double adhesive connecting foil 14 and the cover foil 12of the first embodiment 10. Thus, as is evident from FIG. 1c, the coverfoil 12 is applied in an orientation substantially transversly relativeto the orientation of the epidural catheter 32, the cover foil 12′ isapplied lengthwise or longitudinally relative to the overall orientationof the epidural catheter which is to be fixated by means of the device10′.

[0055]FIG. 3 shows a third embodiment of the epidural catheter fixationdevice 10″ according to the present invention, which embodiment isidentical in shape to the first embodiment 10 presented in FIG. 1a, butits construction is simplified in the respect that this third embodimentdoes not employ the above-mentioned pad 20, providing a simplerconstruction. The succession of layers in the U-shaped assembly oflayers is: the first release foil 16″, the U-shaped pad 24″ withsubstantially even branches, one of the branches being provided with twoopposite grooves 23″, the pad 22″ coplanar with the pad 24″, the doubleadhesive connecting foil 14″, the second release foil 26″, and thethird, intermediate release foil 28″ between the second release foil 26″and the end of the longer branch of the double adhesive connecting foil14″. Any of the above-mentioned embodiments in the FIGS. 2, and 3, whichare not explicitly provided with a inspection window, may be providedwith such a window, and its shape may vary, being, for example,substantially rectangular, oval, elliptic, etc.

[0056]FIG. 4a is a schematic and perspective view of a fourth embodiment10′″ of the epidural catheter fixation device according to the presentinvention, which epidural catheter fixation device 10′″ comprises thefollowing succession of layers: the first release foil 16′″, the coverfoil 12′″ provided with two symmetrical transversal cuts in the medianregion thereof, dividing the cover foil 12′″ into a proximal part and adistal part, and an oblong cutout provided longitudinally from theproximal end towards the median region of the cover foil 12′″, theadhesive layer provided between the release foil 16′″ and the cover foil12′″, the first pad 20′″ adhesively adhered to the distal end of thecutout and following its contours on approximately half the penetrationdepth of the cutout into the proximal part of the cover foil 12′″, andthe second pad 24′″ adhesively adhered to the first pad 20′″ andfollowing the contours of the cutout but on a more reduced length of thecutout periphery than the first pad 20′″. Between one end of the firstpad 20′″ and the cover foil 12′″, a cover foil 28′″ is provided, and thecover foil 12′″ is at the distal end thereof provided with a viewingwindow 32′″ which in the FIGS. 4a and 4 b has the shape of an oblongrectangle with rounded ends, but which may have any other suitableabove-mentioned form, such as circular, oval, elliptic, etc. The fourthembodiment 10′″ of the epidural catheter fixation device according tothe present invention is applied in a manner which is different from theabove-mentioned embodiments, as in the fourth embodiment there is onlyone adhesive layer continuously provided upon the catheter-supporting,skin-attaching proximal part of the catheter fixating device 10′″ andthe catheter-covering distal part of the same catheter fixating device10′″. Consequently, as seen in FIG. 4b, the provision of the twosymmetrical, transversal cuts in the median region of the cover foil12′″ renders it possible to rotate the distal part of the cover foil12′″ 180° so that the adhesive side of the distal part may be superposedthe non-adhesive part of the cover foil 12′″ supporting the first andthe second pad 20′″ and 24′″, respectively, and the catheter 32.

[0057]FIGS. 5a and 5 b are schematic and perspective views of a fifthand preferred embodiment 10 ^(iv) of the epidural catheter fixationdevice 10 _(iv) according to the present invention. The succession oflayers in this fifth embodiment of the present invention is the same asin the first embodiment of the invention, i.e. the first pad 20 ^(iv),the connecting foil 14 ^(iv) having a broad bottom, continuing with anarrowing and evading into a lobe, the cover foil 12 _(iv) partiallyoverlapping the broader lobe of the connecting foil 14 _(iv) andprovided with the inspection window 30 _(iv), and the second and a thirdpad 24 ^(iv) and 22 ^(iv), respectively, attached to the extremity ofthe lobe, the second pad 24 _(iv) being provided with two grooves 23_(iv) for placing the epidural catheter 32. The configuration of thefifth and preferred embodiment is optimized as to limit the requirementsof dexterity from the user's part and also the multiple bending of theepidural catheter 32, thus reducing the risk of constriction of theflow. The epidural catheter 32 is thus placed above the section betweenthe two grooves 23 _(iv), then wrapped around the semicircular curvatureof the pad 24 _(iv), and finally introduced under the pad 22 _(iv) whichadheres to the patients skin, thus ensuring a first step in fixating theepidural catheter 32 to the patient's skin. A second step comprises thefixation of the entire assembly comprising the epidural catheter 32 andthe lobe-shaped part of the connecting foil 14 _(iv) supported on thefirst pad 20 ^(iv) and supporting the second and the third pad 24 ^(iv)and 22 ^(iv), respectively, by folding the cover foil 12 ^(iv) over theassembly along the folding line 17 ^(iv) which marks the transition froma two-layer thickness of the fixation device 10 ^(iv) to a single layer.The third pad 22 ^(iv) has the main function of providing temporarystable support for the epidural catheter 32 ^(iv) after it is wrappedaround the semicircular portion of the second pad 24 _(iv) and before itis introduced under the first pad 20 ^(iv). The finally fixated epiduralcatheter 10 _(iv) is seen in FIG. 5b.

[0058]FIG. 6 is a schematic and perspective view of a preferred methodof producing the first embodiment 10 of an epidural catheter fixationdevice according to the present invention shown in FIGS. 1a, 1 b, 1 cand illustrating the multilayer structure of the epidural catheterfixation device. According to the method illustrated in FIG. 6 a systemof rollers feed and attach to each other by superposition a series oflayers of material. A roller 42 feeds release foil 44, a roller 46 feedsa cover foil 48 which contains an adhesive layer on its lower side, aroller 52 feeds a pad sheet 50 that after stamping generates the pads 22and 24, a roller 56 feeds a double adhesive sheet 54 which overlaps acover foil 48 partially, a roller 60 feeds a pad sheet 58 which adheresto a connecting foil 54, a roller 64 feeds a release foil 62 whichcovers the pad sheet 58, and a roller 68 feeds a release foil 66 whichcovers the release foil 62, the pad sheet 58, the connecting foil 54,and a portion of the non-adhesive side of the cover foil 48. Theresulting multilayer structure is thereafter fed through a stampingmachine which shapes the multilayer material into the desired profile.

EXAMPLE

[0059] The epidural catheter fixation device shown in FIGS. 5a and 5 bwas made from the following materials: The cover foil 12 ^(iv) was madefrom a non-woven polyamide sheet of approx. 45 g/m². The overall lengthof the cover foil 12 ^(iv) was 120 mm and the overall width of themaximum lateral dimension was 98 mm. The transparent film which is partof the two-layered cover foil 12 ^(iv) and covers the inspection window30 ^(iv) was a semi-permeable polyurethane sheet. The adhesive materialapplied to the cover foil 12 ^(iv) was a medical grade acrylic adhesive.The pads 20 _(iv), 22 ^(iv) and 24 ^(iv) were made of polyethylene foam.The connecting foil 14 ^(iv) was a polyethylene foil coated on bothsides with a medical grade acrylic adhesive. The adhesives of thefixating device were covered by a siliconized release paper.

[0060] Although the present invention has been described above withreference to specific, presently preferred embodiments of the fixationdevice according to the present invention, the present invention is,however, by no means to be construed as limited to the aboveembodiments, as numerous modifications, combinations and amendments arereadily perceivable by a person having ordinary skill in the art, withinthe scope of the present invention as defined in the appended claims.

1. A fixation device for fixating a catheter relative to a skin surfacepart of a person, said catheter defining an outer diameter and beingintroduced into the interior of said person through said skin surfacepart substantially perpendicularly relative thereto through aperforation site, comprising: a pad element to be arranged adjacent tosaid perforation site and defining a convex marginal surface having aradius of curvature of at least one order of magnitude larger than saidouter diameter of said catheter, said marginal surface providing asupport surface in relation to said catheter positioned in facialcontact therewith for arranging said catheter in a loop and turning saidcatheter from an orientation substantially perpendicularly relative tosaid skin surface part to an orientation substantially parallelly withsaid skin surface part and for preventing said catheter from slidingalong said marginal surface, a cover foil of a foil material havingopposite first and second surfaces and defining a first end, an adhesivematerial applied to said first surface of said cover foil, and aconnecting foil being connected to said cover foil at said first endthereof and constituting an extension thereof, said pad element beingconnected to and supported by said connecting foil, said connecting foildefining a transition area between said supporting element and saidcover foil, a folding line being defined within said transition area,said cover foil being foldable onto said pad element along said foldingline for arranging said first surface of said cover foil facing towardssaid pad element for adhering to said skin surface part, for fixatingsaid catheter relative to said pad element and for covering saidperforation site.
 2. The device according to claim 1 , said connectingfoil being constituted by a separate foil component, or alternativelysaid connecting foil being integral with said cover foil.
 3. The deviceaccording to any of the claims 1 or 2, said pad element defining a padarea, and said first surface of said cover foil defining an areasubstantially exceeding said pad area.
 4. The device according to any ofthe claims 1-3, said connecting foil being provided with an adhesivecovering at a surface thereof coextensive with said surface of saidcover foil.
 5. The device according to any of the claims 1-4, saidconnecting foil being provided with an adhesive covering at a surfacethereof opposite to said first surface of said cover foil.
 6. The deviceaccording to claim 5 , said connecting foil having an extension forcovering and adhering to said catheter.
 7. The device according to anyof the claims 1-6, said pad element being provided with an adhesivecovering at said convex marginal surface.
 8. The device according to anyof the claims 1-7, said pad element being provided with an adhesivesurface covering.
 9. The device according to any of the claims 1-8, saidconnecting foil providing a fixation support adjacent said pad elementfor attaching said catheter to said skin surface part of said person.10. The device according to any of the claims 1-9, said pad elementhaving two opposed notches.
 11. The device according to any of theclaims 1-10, said cover foil having a transparent area allowing visualinspection of said perforation site.
 12. The device according to any ofthe claims 1-11, said cover foil being covered by a release foilcovering said adhesive material of said first surface of said coverfoil.
 13. The device according to any of the claims 1-12, said coverfoil being of a rectangular configuration, a quadratic configuration, acircular configuration, an elliptic configuration or a combination ofthe above configurations.
 14. The device according to any of the claims1-13, said cover foil being made of a water-permeable material.
 15. Thedevice according to any of the claims 1-14, said cover foil being madeof a water-impermeable material.